Randomizowane badanie kliniczne – leczenie raka szyjki macicy w stadium IIIB sam膮 radioretapi膮 w por贸wnaniu do radioterapii skojarzonej z hipertermi膮.
tytu艂 oryg.: A randomized clinical trial of radiation therapy versus thermoradiotherapy in stage IIIB cervical carcinoma
Wydawnictwo: International Journal of Hyperthermia
Autor g艂贸wny: Yoko Harima
Pozostali autorzy: K. Nagata, K. Harima, V. V. Ostapenko, Y. Tanaka, S. Sawada
Data: 2000-07-17
DOI: 10.1080/02656730903092018
J臋zyk publikacji: angielski
Klasa publikacji: Badanie kliniczne
Randomizowane: TAK
Wieloo艣rodkowe: NIE
Faza badania klinicznego: B/D
Liczba pacjent贸w: 40
Rodzaj HT: LRHT Capacitive
Rodzaj HT opis: Hipertermia miejscowa, g艂臋boka, pojemno艣ciowa
Aparatura: Thermotron RF-8
Jednostka chorobowa: Rak szyjki macicy miejscowo zaawansowany
Symbol Jednostki chorobowej: LACC
Stage: IIIB
Typ skojarzenia HT stosowany w badaniu: HT+RT
Rodzaj CT: Nie dotyczy
Abstract. Background: To clarify the role of thermoradiotherapy for FIGO Stage IIIB cervical carcinomas, both the clinical response and survival of patients treated with radio- or thermoradiotherapy were investigated.
Methods: Forty patients with Stage IIIB uterine cervix carcinoma were treated with external beam irradiation to the pelvis, combined with iridium 192 high-dose-rate intracavitary brachytherapy. All patients were divided randomly into the following two groups: the radiotherapy (RT) group of 20 patients, who underwent radiotherapy alone; and the thermoradiotherapy (TRT) group of 20 patients, who underwent three sessions of hyperthermia in addition to radiotherapy.
Findings: The primary endpoint of this study was local complete response and survival. A complete response was achieved in 50% (10 of 20) in the RT group versus 80% (16 of 20) in the TRT group ( p 藛 0:048). The 3-year overall survival and disease-free survival of the patients who were treated with TRT (58.2 and 63.6%) were better than those of the patients treated with RT (48.1 and 45%), but these diOEerences were not significant. The 3-year local relapse-free survival of the patients who were treated with TRT (79.7%) was significantly better than that of the patients treated with RT (48.5%) ( p 藛 0:048). TRT, as delivered in this trial, as well tolerated and did not significantly add to either the relevant clinical acute or long-term toxicity over radiation alone.
Interpretation: TRT resulted in a better treatment response and 3-year local relapse-free survival rate than RT for patients with FIGO Stage IIIB cervical carcinoma..
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